Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS
- Conditions
- Lumbar Foraminal Stenosis
- Interventions
- Procedure: TLIF and unilateral pedicle screw fixationProcedure: TLIF and bilateral pedicle screw fixationDevice: Pedicle screw and cage
- Registration Number
- NCT02985138
- Lead Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Brief Summary
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
- Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
- Has presence of active malignancy
- Has a history of severe allergy
- Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
- Pregnant, or may become pregnant within follow-up period of study
- Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
- Spondylolisthesis at the target level
- Has undergone previous lumbar surgery
- Has severe osteoporosis (T-score ≤ -3.5)
- BMI > 35kg/m2
- Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilateral fixation Pedicle screw and cage Patients undergoing TLIF and bilateral pedicle screw fixation Unilateral fixation TLIF and unilateral pedicle screw fixation Patients undergoing TLIF and unilateral pedicle screw fixation Bilateral fixation TLIF and bilateral pedicle screw fixation Patients undergoing TLIF and bilateral pedicle screw fixation Unilateral fixation Pedicle screw and cage Patients undergoing TLIF and unilateral pedicle screw fixation
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) scores 2 years postoperatively
- Secondary Outcome Measures
Name Time Method Operative duration 1 week postoperatively Estimated blood loss 1 week postoperatively Foraminal height 2 years postoperatively Radiographic parameters
Fusion rate 2 years postoperatively Adverse events related to procedure 2 years postoperatively Spinal angles 2 years postoperatively Radiographic parameters
Oswestry Disability Index (ODI) 2 years postoperatively Cost of treatment 2 years postoperatively Length of hospital stay 1 week after discharge Intervertebral space height 2 years postoperatively Radiographic parameters
Trial Locations
- Locations (1)
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
🇨🇳Shanghai, China